MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS

Device Problems Failure to Deliver (2338); Computer System Security Problem (2899); Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015); Reset Problem (3019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided within a follow-up report.

Event Description

It was reported that during ventilation a white screen appeared.Log analysis revealed that the device performed a reboot.No injury reported.

Manufacturer Narrative

The electronic logfile was available for investigation.The logbook entries stored before the reboots do match with available test results and log entries observed for an already known vulnerability of the perseus medibus interface.Although the complained issue was not reproduced with the particular customer workplace configurations, the reboot was obviously caused by large medibus incompatible data packages.Only sw versions 2.0n are affected by the identified medibus vulnerability.The software sub module for the medibus interface has already been improved and will be distributed as part of the new perseus software release 2.03.The distribution of the sw2.03 will be carried out with this field safety corrective action.All customers of draeger perseus a500 anesthesia machines equipped with sw2.0n will be informed with a field safety notice about the identified risk.All devices equipped with the affected sw versions 2.0n will be upgraded to sw2.03.Sw2.03 has already been installed on this particular device.

Event Description

It was reported that during ventilation a white screen appeared.Log analysis revealed that the device performed a reboot.No injury reported.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10372388
• MDR Text Key: 207172879
• Report Number: 9611500-2020-00273
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1